MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION

Model Number	TCN-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient that is enrolled in the a4087 rapid clinical study experienced a migraine that was moderate in severity.The patient was prescribed medication and the event resolved the next day.The event was assessed as possibly related to the device, however there are no implanted devices and the patients' radiofrequency procedures were (b)(6) 2022 in the mid/low back region and (b)(6) 2022 to the right side.
Event or Problem Description
It was reported that the patient that is enrolled in the a4087 rapid clinical study experienced a migraine that was moderate in severity.The patient was prescribed medication and the event resolved the next day.The event was assessed as possibly related to the device, however there are no implanted devices.The patient underwent two separate radiofrequency procedures, the first on (b)(6) 2022 in the mid/low back region and the second on (b)(6) 2022 to the right side.Additional information was received that the physician believes that the patient's headache may have been caused by irritation of the cervical area.

• Brand Name: NA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16721807
• Report Number: 3006630150-2023-01942
• Device Sequence Number: 12750048
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TCN-10
• Device Catalogue Number: TCN-10
• Device Lot Number: 22912231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female